Application 078090
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GRANISETRON HYDROCHLORIDE | GRANISETRON HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 4MG BASE/4ML (EQ 1MG BASE/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-319 | Granisetron | GRANISETRON HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-319 | Granisetron | GRANISETRON HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-319 | Granisetron | GRANISETRON HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31329 | SUPPL | 2014-09-24 |
| 39552 | SUPPL | 2014-09-23 |